Medtronic has entered into an agreement to settle existing U.S. lawsuits relating to its Sprint Fidelis family of defibrillation leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949) that were the subject of a field action announced Oct. 15, 2007.
Under the terms of the agreement, the Minneapolis-based company has agreed, "subject to certain conditions," to settle U.S. lawsuits and claims pending as of Oct. 15, for a total payment of $268 million. The payment includes an amount for attorneys’ fees and administrative expenses.
According to Medtronic, the parties will file joint requests to terminate the multi-district litigation (MDL) and Minnesota state court proceedings related to the Sprint Fidelis leads and to dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.
The parties also will request dismissal of other Fidelis-related cases throughout the U.S., said Medtronic, adding that the company “can cancel the agreement if certain conditions are not met, and the agreement can be terminated by either party if the MDL proceedings are not terminated.”
The cases in the settlement are those arising in the U.S. from the Oct. 15, 2007 Sprint Fidelis field action, including cases currently filed either in the MDL or in state courts. The sale of the devices were initially suspended Oct. 15, 2007, due to reports of lead fractures.
“All settling plaintiffs must satisfy any insurance claims and subrogation interests of Medicare or Medicaid from their settlement payments,” Medtronic said. “No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys’ fees.”
The settlement is a compromise of disputed claims, and the parties have not admitted any liability or the validity of any defense in the litigation. Medtronic expects to record the Sprint Fidelis lead litigation settlements as a special charge in its second fiscal quarter, ending Oct. 29.